Bugten Vegard, Nordgård Ståle, Skogvoll Eirik, Steinsvåg Sverre
Department of Otolaryngology, Head and Neck Surgery, St. Olav University Hospital of Trondheim, Trondheim, Norway.
Laryngoscope. 2006 Jan;116(1):83-8. doi: 10.1097/01.mlg.0000184581.67185.6e.
OBJECTIVES/HYPOTHESIS: The aim of this study was to evaluate the effects of a nonabsorbable packing (NAP) in the middle meatus (MM) for 5 days after sinus surgery.
A randomized, partly blinded, controlled clinical trial.
Sixty-one patients (M/F = 30/31, mean age 42, range 18-72) with chronic or acute recurrent rhinosinusitis were included. Fifty-nine underwent surgery. Thirty-one had NAP in the MM for 5 days, and 28 served as controls with daily saline irrigations postoperatively. Primary outcome variables were nasal congestion, nasal pain, and headache the first 2 weeks rated on visual analogue scales (VAS; 0-100) and the amount of postoperative bleeding recorded on an ordinal scale (1-4). Secondary outcome variable was the extent of adhesions in MM 10 to 14 weeks after surgery judged by blinded evaluation of endoscopic video recordings.
Fifty-eight patients completed a diary. No significant differences in primary outcome variables between the groups were found. Nasal congestion decreased most the first 5 to 7 days postoperatively. Removal of the NAP caused little pain (mean 23 on VAS). Temporary bleeding occurred in three patients. Bilateral adhesions were observed in 10 control patients but in none with NAP. Unilateral adhesions were found in nine control patients and in seven with NAP (exact P < .001).
NAP in the MM for 5 days significantly reduced the extent of adhesions in MM compared with saline irrigation alone. NAP did not cause additional discomfort.
目的/假设:本研究的目的是评估鼻窦手术后在中鼻道(MM)放置不可吸收填充物(NAP)5天的效果。
一项随机、部分盲法、对照临床试验。
纳入61例慢性或急性复发性鼻-鼻窦炎患者(男/女 = 30/31,平均年龄42岁,范围18 - 72岁)。59例接受了手术。31例在中鼻道放置NAP 5天,28例作为对照组,术后每天用生理盐水冲洗。主要结局变量为术后前2周用视觉模拟量表(VAS;0 - 100)评估的鼻充血、鼻痛和头痛情况,以及用序数量表(1 - 4)记录的术后出血量。次要结局变量是术后10至14周通过对内窥镜视频记录进行盲法评估判断的中鼻道粘连程度。
58例患者完成了日记记录。两组之间在主要结局变量上未发现显著差异。术后第1个5至7天鼻充血缓解最为明显。取出NAP时几乎没有疼痛(VAS平均为23)。3例患者出现暂时性出血。10例对照组患者观察到双侧粘连,而NAP组无一例出现。9例对照组患者和7例NAP组患者发现单侧粘连(确切P <.001)。
与单纯生理盐水冲洗相比,在中鼻道放置NAP 5天可显著降低中鼻道粘连程度。NAP未引起额外不适。